FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (ENDO USA, Inc.)

View source ↗

Summary

FDA approved an original Abbreviated New Drug Application for sapropterin dihydrochloride from ENDO USA, Inc., enabling a generic option for phenylketonuria. Sa…

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Hyperphenylalaninemia
• Phenylketonuria

Drugs mentioned

• Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)